Senior Specialist Quality Assurance, CSV
Our client is a Nasdaq-listed biopharmaceutical company focused on developing accessible, scientifically rigorous therapeutics for mental health disorders, including generalized anxiety, major depressive disorder, post-traumatic stress disorder, and autism spectrum disorder.
About the role
The Senior Specialist Quality Assurance, CSV ensures computerized systems comply with regulatory and quality standards throughout their lifecycle. This role supports system validation, vendor evaluations, and change management to uphold data integrity and regulatory compliance, serving as a key quality assurance resource for IT and business teams.
Responsibilities
- Collaborate with IT and business teams to implement and maintain compliant computerized systems
- Provide quality oversight ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards
- Serve as QA CSV subject matter expert during vendor evaluations and system qualification
- Support SOP development, training, and change control for continuous improvement
- Ensure Software Development Lifecycle and validation requirements are clearly defined and met
- Lead investigations of CSV-related deviations and data integrity issues
- Review and approve validation documentation including protocols and reports
- Advise on data integrity best practices
- Maintain inspection readiness in partnership with IT
- Review system releases and change controls from a QA perspective
- Perform internal audits to ensure steady state system maintenance and user control
- Support QA oversight for AI/ML-enabled GxP systems including risk assessment
Requirements
- Minimum 7 years in the pharmaceutical or biotech industry
- At least 5 years’ experience managing CSV validation lifecycle
- Bachelor’s degree in life sciences
- Strong knowledge of 21 CFR Part 11, Annex 11, CSV, CSA, GDPR, GAMP 5, and IT SDLC best practices
- Experience validating SaaS/PaaS GxP systems
- Understanding of technology implementation and data migration strategies
- Experience with AI/ML system validation and risk management in regulated settings
- Demonstrated ability to review validation deliverables such as requirements and test scripts
Pay
Starting base pay range: $101,147.00 – $122,757.00. Compensation is based on skills, experience, and location, with eligibility for additional bonus and equity.
Benefits
- 100% paid health benefits (Medical, Dental, and Vision) for employees and dependents
- 401(k) program with company match and vesting after the first month
- Flexible time off
- Generous parental leave